FDA 510(k) Application Details - K031978

Device Classification Name Tester, Auditory Impedance

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510(K) Number K031978
Device Name Tester, Auditory Impedance
Applicant AMPLAID
PO BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 874.1090

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Classification Product Code ETY
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Date Received 06/26/2003
Decision Date 07/21/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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